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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Full Field Digital, System, X-Ray, Mammographic
510(k) Number K103485
Device Name SENOGRAPH DS, SENOGRAPH ESSENSTIAL
Applicant
General Electric Company
3000 N. Grandview Blvd.
W-709
Waukesha,  WI  53188
Applicant Contact STEVEN KACHELMEYER
Correspondent
General Electric Company
3000 N. Grandview Blvd.
W-709
Waukesha,  WI  53188
Correspondent Contact STEVEN KACHELMEYER
Regulation Number892.1715
Classification Product Code
MUE  
Date Received11/26/2010
Decision Date 10/06/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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